BEUDAMED
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    Carbomedics VT-200 Valve Tester

    FDA Recall
    Terminated ·Carbomedics, Inc·Product code DTJ·April 30, 2002

    DT2 Mammo, Size 8 x 10 inch, Ref No. E2RN6. Agfa Corporation. Greenville, SC 29601. Intended to display mammographic images.

    FDA Recall
    Terminated ·AGFA Corp.·Product code LLZ·April 22, 2010

    AXIOM Artis dTA, Model Number 7008605

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    AXIOM Artis dTC, Model Number 7413078

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

    Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Model Numbers: System Material # AXIOM Artis FC 05904433; AXIOM Artis FA 05904441; AXIOM Artis MP 05904466; AXIOM Artis BC 05904649; AXIOM Artis BA 05904656; AXIOM Artis dBC Mag. Nav. 05917054; AXIOM Artis TA 07007755; AXIOM Artis dTA 07008605; AXIOM Artis dFC 07412807; AXIOM Artis dTC 07413078; AXIOM Artis dBA 07555357; AXIOM Artis dMP 07555365; AXIOM Artis dFA 07555373; AXIOM Artis dFC Mag. Nav. 07727717; AXIOM Artis TC 07728350; AXIOM Artis dBC 07728392; Artis zee floor 10094135; Artis zee ceiling 10094137; Artis zee MP 10094139; Artis zee biplane 10094141; Artis zee floor MN 10094142; Artis zee biplane MN 10094143; Artis Q floor 10848280; Artis Q ceiling 10848281; Artis Q biplane 10848282; Artis Q.zen floor 10848353; Artis Q.zen ceiling 10848354; Artis Q.zen biplane 10848355.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·May 5, 2021

    SOMATOM Definition AS, a family of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission dta from either the same axial plane taken at different angles or spiral planes taken at different angles.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 20, 2016

    Boston Scientific, Ultra-thin" Diamond" Balloon Dilatation Catheters, M001164040 (DT/3-4/5/40, 16-404), M001164360 (DT/5-2/5/40, 16-436),M001164620 (DT/6-4/5/40, 16-462), Made in Ireland, Ballybrit Business Park, Galway, Ireland Recommended for Percutaneous Transluminal Angioplasty of the iliac, femoral and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·February 18, 2010

    DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.

    FDA Recall
    Terminated ·DT MedTech, LLC·Product code NTG·September 25, 2018

    DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.

    FDA Recall
    Terminated ·DT MedTech, LLC·Product code NTG·September 25, 2018

    ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25 The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code DLJ·September 13, 2010

    ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code DKJ·June 29, 2017

    Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantitative determination of salicylate concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKJ·April 3, 2017

    Multigent Vancomycin Calibrators; Manufactured by Microgenics Corp, Fremont, CA. Distributed by: Abbott Diagnostics, Abbott Park, IL Product Usage: The Multigent Vancomycin calibrators are intended for use in the calibration of the multiagent vancomycin Vancomycin is a commonly used antibiotic to treat staphylococcus and other gram-positive bacterial infections.

    FDA Recall
    Terminated ·Microgenics Corp·Product code DLJ·June 8, 2011

    Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC, 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Lin-Zhi International Inc·Product code DLJ·February 6, 2014

    Tobramycin Calibrators, REF 7F93-01; Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538; Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064. .Tobramycin is a commonly used antibiotic to treat bacterial infections, in particular gram negative infections.

    FDA Recall
    Terminated ·Microgenics Corp·Product code DLJ·November 11, 2011

    TDx/TDxFLx Salicylate, list 9533-60; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code DKJ--·December 5, 2003

    VITROS Chemistry Products SALI Slides packaged as 90 slides/pack catalog number 1314343 VITROS SALI Slides quantitatively measure salicylate (SALI) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code DKJ·June 12, 2013

    Salicylate-SL, in vitro diagnostic, Cat. No.511-20, Lot No. 29892

    FDA Recall
    Terminated ·Diagnostic Chemicals, Ltd.·Product code DKJ·December 5, 2006

    SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code DKJ·October 22, 2007

    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.

    FDA Recall
    Terminated ·Microgenics Corporation·Product code DKJ·July 25, 2016